Multiple sclerosis drug linked to liver injury

[missvicki]

I know this is not great news for some but thought you would want to know.


http://www.msnbc.msn.com/id/23375161/

[HarryZ]

This is a link that I picked up from another MS website. It's a letter from Biogen/Elan that was written to health care professionals re: the problem.

http://www.fda.gov/medwatch/safety/2008 ... letter.pdf


What puzzles me is that it refers to problems that are being discovered in the "post marketing" period use of Tysabri. This drug was in trials for more than two years for both MS and Crohn's patients. During trials, patients are monitored very closely for problems like this. Are we now being told that this alert is something new and that Biogen/Elan were not aware of it prior to this time?

Harry

[2gentle]

Thanks Harry for posting this. Several of my MS friends won't even consider taking Tysabri, because they believe it was released too soon.

I agree w/them 100%!But then I think most meds are released waaay before they should be.

Gentle

[Jean]

That's not very surprising to me. Many treatments may be linked to liver injury. Even high-dose paracetamol may cause liver damage ! And the interferons too. That's why people treated with Avonex, Betaseron or Rebiff have to make blood draws regularly to check liver function. [/quote]

[Lyon]

.

[HarryZ]

That's not very surprising to me. Many treatments may be linked to liver injury. Even high-dose paracetamol may cause liver damage ! And the interferons too. That's why people treated with Avonex, Betaseron or Rebiff have to make blood draws regularly to check liver function.

You are right in stating that it isn't surprising that liver problems can occur from using very powerful drugs like Tysabri.

What I DO find surprising is that Biogen/Elan are just now issuing a warning to physicians about this problem that they state has only recently begun to show up. My question is why this kind of problem wasn't discovered in over two years of MS and Crohn's trials.

Harry

[Jean]

You're right. That's not the same problem. But,

...the liver risk has been debated since at least last year, including at an FDA advisory panel.

(msnbc article)

In fact, I think the liver problem was already suspected, but with a 1/1000 ratio, it was probably not seen during trials (1/1000, that's difficult to see, even for a phase III trial)

This announcement is probably the "official" warning of Biogen. By doing this, they protect themselves against claims for "hidden side effects" which could be issued.

[HarryZ]

In fact, I think the liver problem was already suspected, but with a 1/1000 ratio, it was probably not seen during trials (1/1000, that's difficult to see, even for a phase III trial)

The 1/1000 number was a Biogen "estimate" for "severe liver damage". How many other liver problems are occurring with Tysabri? ! The article went on to say that in a number of cases, the liver problems stopped when the drug was stopped and then they re-appeared when Tysabri was started again. You begin to wonder just what "a number of cases" means! I'm sorry that I just don't trust Biogen in all of this.

This announcement is probably the "official" warning of Biogen. By doing this, they protect themselves against claims for "hidden side effects" which could be issued.

Why do I fear that this is just the tip of the iceberg of Tysabri problems to come?!

Harry

[trrish]

I think it is easy to fear that. It's a new and powerful drug. Thought I can't imagine that most drugs don't cause some impact on the liver, actually.

Because I'm on Tysabri, I choose not to be driven by fear about it. It has helped me immensely when none of the other drugs did. I am very aware, though, that it may all come to a screeching halt. I guess it is a tradeoff that so far, I've been willing to make. It's better to have loved and lost?